Systems, methods, and compositions for achieving closure of vascular puncture sites

Abstract

Systems and methods convey a closure material into a catheter, e.g., to seal a puncture site in a blood vessel. The closure material comprises a mixture of first and second components, which, upon mixing, undergo a reaction to form solid closure material composition. The first component may be a lyophilized polyethylene glycol (PEG) material contained within a vial. The second component may be a buffered albumin solution plus water contained within a syringe. An applicator provides easy and effective mixing of the components and delivery of the mixture to the puncture site.

1. An assembly comprising
 a biocompatible polymer in lyophilized form, 
 a first container holding the polymer in lyophilized form, the first container including a fluid receiving end, 
 a protein solution, 
 a second container holding the protein solution including a fluid dispensing end and a single actuator for expelling the protein solution from the fluid dispensing end, and 
 applicator to join the fluid receiving end of the first container with the fluid dispensing end of the second container to introduce the protein solution into the first container for mixing with the polymer in lyophilized form to reconstitute the polymer and form a mixture, wherein, upon mixing, the protein solution and the polymer cross-link, the applicator including a first fluid passage adapted to join the fluid dispensing end of the second container in fluid communication with the fluid receiving end of the first container, the first fluid passage including a distal end region that, when the fluid dispensing end of the second container is joined in fluid communication with the fluid receiving end of the first container, extends into the first container to contact the polymer in lyophilized form, the distal end region including a plurality of holes in a side of the distal end region for uniformly introducing the protein solution into the first container for mixing with the polymer in response to operation of the single actuator, the applicator further including a second fluid passage next to the first fluid passage for conveying the mixture from the first container concurrent with introduction of the protein solution into the first container in response to operation of the single actuator.